eligibility_summary
Adults ≥18, ECOG 0–2, biopsy‑proven systemic AL amyloidosis with measurable clonal disease and symptomatic organ involvement, prior CD38 mAb + proteasome inhibitor and not in VGPR/CR or relapsed. Excludes: prior CAR‑T/BCMA, MM with >30% marrow PCs, severe cardiac disease (NYHA III/IV, LVEF<35%, stage IIIb), recent stroke/seizure, organ/marrow dysfunction, active infection or HIV/HBV/HCV viremia, other active malignancy, non‑AL or soft‑tissue only, hypotension, pregnancy, uncontrolled comorbidities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06097832 is an open-label phase 1b/2, single-arm dose-escalation/expansion trial in relapsed/refractory AL amyloidosis testing NXC-201 (HBI0101), an autologous anti-BCMA chimeric antigen receptor T-cell therapy (CAR-T) made by ex vivo retroviral transduction and infused fresh. Mechanism: CAR-T cells bind BCMA (TNFRSF17) on clonal plasma cells and induce targeted cytotoxicity to eradicate light chain–producing cells, lowering amyloidogenic free light chains. Lymphodepletion uses cyclophosphamide (alkylating DNA crosslinker) plus fludarabine (purine analog DNA synthesis inhibitor) to support CAR-T expansion. Targets: BCMA-expressing plasma cells. Pathways: BCMA signaling on plasma cells and T-cell activation/cytotoxic effector pathways. Doses: 150×10^6 or 450×10^6 CAR+ T cells.